Aspirin

Description

RESTORE u is an adult low dose aspirin formulation, containing 81 mg of aspirin per tablet. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and is designed for pain relief. Each bottle contains 120 enteric-coated tablets, which are safety coated to minimize gastrointestinal irritation. The product is comparable to the active ingredient found in St. Joseph® Low Dose Aspirin. The National Drug Code (NDC) for RESTORE u is 57344-146-08.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains. Healthcare professionals are advised to consult with patients regarding any additional uses for this product.

There are no teratogenic effects associated with this drug. Furthermore, no nonteratogenic effects have been reported.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage must not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, the use of this medication is not recommended unless specifically directed by a physician.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries the risk of severe stomach bleeding. The likelihood of such an event is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily while using this product, or exceed the recommended dosage or duration of use.

Individuals should refrain from using this product if they are allergic to aspirin or any other pain reliever or fever reducer. Prior to use, it is advisable to consult a healthcare professional if any of the following conditions apply: a history of stomach bleeding, existing stomach issues such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, or a diagnosis of asthma. Additionally, consultation with a doctor or pharmacist is recommended for those taking prescription medications for diabetes, gout, or arthritis.

In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Users should discontinue use and contact a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, presence of redness or swelling, emergence of new symptoms, or occurrences of ringing in the ears or hearing loss. These symptoms may signify a serious medical condition requiring prompt attention.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye's syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid this product. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Aspirin, the active ingredient in this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, asthma (wheezing), and shock. Patients should seek immediate medical attention if they experience any signs of an allergic reaction.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of this adverse reaction is increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using this product, or exceed the recommended dosage or duration of use.

Patients are advised to stop using the product and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, if redness or swelling occurs, if new symptoms arise, or if there is ringing in the ears or loss of hearing, medical advice should be sought.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also seek medical advice prior to use.

It is important to note that this product should not be used by individuals who are allergic to aspirin or any other pain reliever or fever reducer.

Drug Interactions

Aspirin has the potential to cause severe gastrointestinal bleeding, particularly when co-administered with anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen. Clinicians should exercise caution and consider monitoring for signs of gastrointestinal bleeding in patients receiving these combinations.

Additionally, it is advisable for patients to consult a healthcare professional prior to initiating aspirin therapy if they are concurrently taking prescription medications for diabetes, gout, or arthritis. This consultation is essential to evaluate the risk of potential interactions and to determine the appropriateness of aspirin use in these contexts.

Packaging & NDC

Below are the non-prescription pack sizes of Aspirin. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should not use this product unless directed by a healthcare professional. There is a significant risk of Reye's syndrome associated with the use of this product in children and teenagers who have or are recovering from chicken pox or flu-like symptoms.

In the event of behavioral changes accompanied by nausea and vomiting, it is crucial to consult a doctor, as these may be early indicators of Reye's syndrome. For patients aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in a 24-hour period unless otherwise directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about any relevant medical history that may heighten the risk of gastrointestinal complications. Close monitoring of these patients is advised to ensure safety and to mitigate potential adverse effects associated with the use of this medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have conditions such as liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring due to the potential impact of compromised liver function on the pharmacokinetics of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and appropriate management strategies should be implemented based on the clinical presentation.

Healthcare providers are encouraged to monitor the patient closely and provide supportive care as needed. This may include symptomatic treatment and stabilization of vital signs. In cases where specific antidotes or treatments are available, they should be administered according to established protocols.

Overall, the management of overdose requires a coordinated approach, emphasizing the importance of rapid response and adherence to clinical guidelines.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has indicated that aspirin may lead to severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), and shock. Additionally, reports of stomach bleeding have been documented, particularly among patients aged 60 years or older, those with a history of stomach ulcers or bleeding issues, individuals taking anticoagulant or steroid medications, and patients using other NSAIDs, whether prescription or nonprescription. Increased risk has also been noted in individuals consuming three or more alcoholic drinks daily while using aspirin or those who exceed the recommended dosage or duration of use.

Signs of stomach bleeding reported in postmarketing experience include symptoms such as feeling faint, vomiting blood, passing bloody or black stools, and experiencing persistent stomach pain. Furthermore, new symptoms such as tinnitus (ringing in the ears) or hearing loss have been reported, which may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Patients must be informed not to use this medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. They should be counseled to stop use and consult a doctor if they experience any signs of an allergic reaction, which may require immediate medical attention. Additionally, patients should be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical advice if their pain worsens or persists for more than 10 days, if redness or swelling occurs, if new symptoms develop, or if they experience ringing in the ears or loss of hearing.

Before using this medication, patients should be encouraged to consult a doctor if any of the following apply: they have a history of stomach problems such as heartburn, they are at risk for stomach bleeding, they have high blood pressure, heart disease, liver cirrhosis, or kidney disease, they are taking a diuretic, or they have asthma.

Furthermore, patients should be advised to speak with a doctor or pharmacist before using this medication if they are currently taking prescription drugs for diabetes, gout, or arthritis to ensure safe and effective use.

Storage and Handling

The product is supplied in a carton that contains essential information and warnings. It should be stored in a dry place at a temperature range of 20°-25°C (68°-77°F) to ensure optimal stability and efficacy. It is important to retain the carton for complete product information and any necessary warnings.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 4 to 8 tablets every 4 hours, not exceeding 48 tablets in a 24-hour period unless directed by a physician. For children under 12 years, use is not recommended unless specifically directed by a healthcare provider.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is particularly important to avoid aspirin in the last trimester of pregnancy unless explicitly instructed by a healthcare professional, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

This file contains official product information for Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)